Kornimate/medical-research-clean huggingface dataset:
a phase i study of e7050 in subjects with solid tumors

Conditions: Solid Tumor; Gastric Cancer

Summary: the purpose of this study is to investigate the tolerability, safety, pharmacokinetics (pk), pharmacodynamics (pd) and anti-tumor activity of e7050 when administered orally once daily to patients with advanced solid tumor and gastric cancer.


Eligibility criteria:
inclusion criteria 1. aged from 20 to less than 75 years old at the time of obtaining informed consent. 2. histological or cytological diagnosis of solid tumors. 3. subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available. 4. adequate organ function. 5. subjects who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug. 6. performance status (ps) 0-1 established by eastern cooperative oncology group (ecog). 7. expected to survive for 3 months or longer after starting administration of the investigational drug. exclusion criteria 1. females who are pregnant or breastfeeding. 2. brain metastases with clinical symptoms or which requires treatment. 3. serious complications or disease history. 4. subjects who cannot take oral medication. 5. using antiplatelet/anticoagulant drugs. 6. continuous using of drugs or foods that strongly inhibit or induce cyp3a4/5 or cyp2d6 during the study period. 7. scheduled for surgery during the study period. 8. known to be hiv, hbv or hcv positive. 9. suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of anti-psychotics or have had a suicide attempt(s) within approximately the last 2 years. 10. history of drug or alcohol dependency or abuse within 2 years. 11. presence of a progressive central nervous system (cns) disease, including degenerative cns diseases and progressive tumors. 12. received any other investigational product or device within 4 weeks before administration.

Keywords: cancer gastrointestinal cancer
internet-delivered cbt for functional abdominal pain in adolescents - a pilot

Conditions: Functional Gastrointestinal Disorders; Abdominal Pain; Dyspepsia

Summary: this pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered cbt-program adjusted for adolescents with functional abdominal pain and functional dyspepsia.

functional abdominal pain (fap) and functional dyspepsia, are common in adolescents and associated with impaired quality of life. in adults with ibs, internet-delivered cbt leads to reduced symptoms and increased quality of life, but studies in children are lacking. this pilot-study aim to evaluate the treatment effects and feasibility of an internet-delivered cbt-program for adolescents with fap and fd. method: pilot study with a pre-post-design and no control group. the internet-delivered cbt-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.

Eligibility criteria:
inclusion criteria: * age 13-17 at inclusion date * fulfilling rome iii-criteria for fap or fd with: 1. a written diagnosis from patient's physician and negative required tests (blood samples: c-reactive protein or erythrocyte sedimentation rate, blood count and iga-transglutaminase. stool: f-calprotectin) 2. the rome iii questionnaire + clinical interview confirming the diagnosis exclusion criteria: * concurrent serious medical conditions * concurrent serous psychiatric diagnosis * on-going psychological treatment * absence from school exceeding an average of 2 days a week is a cause for exclusion since high absence demands more intensive interventions than can be offered in icbt * on-going abuse or severe parental psychiatric illness in the family * pronounced language skill deficits and learning difficulties lead to exclusion from the study * lack of regular internet-access
prognostic factors after liver transplantation

Conditions: Liver Diseases; Liver Transplant; Complications

Summary: the study retrospectively reviewed the medical records of patients who received adult liver transplantation in changhua christian hospital from 2002 to 2019. we collected their personal data about liver disease, laboratory data about liver function, pre-transplant evaluation and post-transplant outcome. we investigate what prognostic factors may contribute a good survival outcome, and improve our clinical practice.


Eligibility criteria:
inclusion criteria: * patients who received adult liver transplantation in changhua christian hospital from 2002 to 2019 exclusion criteria: * patients who did not have suitable donor for liver transplantation

Keywords: liver transplantation chronic liver disease viral hepatitis alcoholic liver disease
combined dry powder tobramycin and nebulized colistin inhalation in cf patients

Conditions: Cystic Fibrosis With Pulmonary Manifestations

Summary: to assess whether the inhalative combination of tobramycin/colistin is more effective in reducing pseudomonas colony forming units (cfus) and improvement of lung function than colistin in mono-therapy.

cystic fibrosis (cf), the most common autosomal recessive disorder in western countries, is caused by mutations of the cystic fibrosis transmembrane conductance regulator molecule (cftr) and affects approximately 40.000 patients in europe. the majority of cf patients develop chronic pulmonary infections with pseudomonas aeruginosa. these are normally treated with single antibiotics, administered orally, intravenously or inhalatively. once the infection becomes chronic, eradication of the pathogen is not any more possible due to biofilm formation of the pathogen and increasing resistance. however, inhalative antibiotic combination therapy might be more efficient than single antibiotic therapy in chronically infected cf patients. this notion is supported by previous in vitro and animal studies using tobramycin/colistin combination therapy. importantly, a pilot study in five cf patients who inhaled consecutively colistin and tobramycin solutions for 4 week, revealed a decrease of log10 2.52 ± 2.5 cfu of p. aeruginosa in sputum specimens during the course of the treatment compared to baseline values (p=0.027). the treatment was shown to be safe and well tolerated. however, forced expiratory volume in 1 sec (fev1) did not differ significantly. taking advantage of the new development of dry powder inhalation (dpi) antibiotics, specifically tobi© podhaler, a larger randomised trial has been performed in which the combined tobi© podhaler and colistin treatment is compared to the monotherapy with colistin.

Eligibility criteria:
inclusion criteria: 1. cystic fibrosis is verified; 2. patient is 12 years or older; 3. fev1 is higher than 25% and lower than 100%; 4. the patients' lung is colonised with p. aeruginosa chronically (≥6 months); 5. p. aeruginosa must be sensitive for tobramycin or colistin; 6. pretreated with colistin \>2 months; 7. last i.v. antibiotic treatment ≥2 weeks; 8. informed consent is given by patients/legal representatives exclusion criteria: 1. clinical deterioration is present (exacerbation symptoms); 2. last tobramycin inhalation treatment ≤ 2 weeks; 3. renal dysfunction (creatinine \<1.5 fold of normal, glomerular filtration rate (gfr) \<80%) at baseline 4. auditoria or vestibular dysfunction, hearing loss 5. intolerances against tobramycin, colistin or polymyxin b 6. myasthenia gravis 7. porphyria 8. pregnancy and nursing

Keywords: chronic pulmonary infection
pulmonary fibrosis biomarker cohort - a prospective cohort of incident patients with ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: incident patients with idiopathic pulmonary fibrosis (ipf) in denmark will be offered inclusion and followed up for up to 5 years with measurements of blood biomarkers and measurements of disease progression.

ipf pathogenesis is complex, including epithelial injury, resident fibroblast-myofibroblast transformation, recruitment of fibrocytes, macrophage activation, and release of numerous cytokines and chemokines. several of these processes release potential biomarker proteins into the blood stream or onto the epithelial surface where they can be measured. biomarkers have mainly two potential roles in ipf. firstly, a diagnostic biomarker would distinguish ipf from other diseases with similar symptoms, facilitating diagnosis and possibly decreasing the need for risky procedures, such as surgical lung biopsy. secondly, a prognostic biomarker would distinguish rapid progressors from slow progressors, which is difficult today. this study will prospectively include patients at the two largest centres in denmark where patients are treated for ipf and has thus a good opportunity to include the majority of incident cases of ipf in denmark. the blood levels of several promising biomarkers will be measured at baseline and during up to 5 years follow-up. patients will also be followed up through regular clinical examination and by querying national registries to determine disease progression, mortality, healthcare utilization and selected co-morbidities. the database will be used for determination of risk factors for the outcomes listed above. sub-group analyses are planned in respect to sex, treatment, radiologic imaging, smoking status, clinical data such as pulmonary function tests, co-morbidities (both pulmonary disease and extra-pulmonary disease), and disease severity at baseline. a research biobank with blood samples is established from the study population. this biobank, and the database of newly diagnosed ipf patients, will be used for future research in ipf. the prospectively created database will also be used for future research in ipf.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pulmonary fibrosis according to the 2011 guidelines by the american thoracic cosicety (ats) and european respiratory society (ers) exclusion criteria: * age lower than 18 years * unable to provide informed consent to participation

Keywords: diagnosis prognosis biomarker
visual quality and contrast sensitivity function for limbal dermoid children after corneal transplantation

Conditions: Limbal Dermoid

Summary: this study is to inquiry the contrast sensitivity function in the 50 eyes of limbal dermoid children with keratoplasty with quick contrast sensitivity function (quick csf) test, as well asa to analyze its relationship between visual quality.

limbal dermoid(ld) is a congenital benign tumor that consist of overgrowths of epidermal appendages that influence vision and cause visual abnormalities due to the induced corneal astigmatism. a large proportion of patients, all of whom had epibular dermoids, has amblyopia. in a previous study, keratoplasty, such as lkp (lamellar keratoplasty) or pkp (penetrating keratoplasty), was shown to facilitate the reconstruction of appearance, and improve visual acuity significantly postoperatively. however, the reestablishment of visual acuity and visual function are always ignored by parents after visual appearance recovery. several studies have evaluated the visual acuity and objective and subjective visual function of patients after keratoplasty. these outcomes include contrast sensitivity (cs), refractive error, graft clarity, anterior and posterior corneal higher order aberration, and vision-related quality of life. although a subjective visual function assessment has been deemed critical, postkeratoplasty patients with vision complaints are not uncommon despite clear grafts and relatively good visual acuity, and the visual function evaluation for ld were relatively less. 50 eyes of 50 limbal dermoid children with corneal transplantation more than 1 year were included in this study. all participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick csf under full optical correction, 9-sf life quality questionnaire and fundus examination. then the normal group would be covered by the positive spherical lens of 1.0d to 6.0d to repress the bcva to 0.1 to 0.9 respectively to compare the visual functions with the keratoplasty patients on the same visual acuity.

Eligibility criteria:
inclusion criteria: * accept the corneal transplantation based on the clinical diagnosis of ocular surface disease; * more than 7 and less than 60 years old; * absence of other ocular disorders and no history of eye surgery and other systemic diseases. exclusion criteria: * less than 7 or more than 60 years old; * with the history of eye surgery and other systemic diseases.

Keywords: keratopathy visual quality contrast sensitivity function
a blinded comparison trial of two topical creams to reduce thigh girth and to smooth thigh skin in women

Conditions: Weight Loss

Summary: the purpose of this study is to evaluate efficacy of two lipolytic creams differing in their bases and demonstrate that their herbal ingredients can reduce the size of the thigh and smooth the appearance of the thigh skin. it is hypothesized that creams with two different cream bases containing herbal products that stimulate the lipolytic process through stimulation of the beta-adrenergic receptor, with one cream base applied to each thigh daily 5 days a week for 4 weeks will reduce thigh girth and smooth the thigh skin compared to baseline.

participants will apply one cream (a) to one thigh and the second cream (b) to the other thigh under the supervision of a female clinic staff. the thigh to which each cream will be applied will be selected randomly, but half of the subjects will have cream a on the right thigh and cream b on the opposite thigh while the other half of the subjects will have the sides reversed. to evaluate the primary endpoint, both thighs will be measured at baseline and at the end of each treatment week, and the secondary endpoint will be assessed with standardized pictures of each thigh at baseline and on the last day of the fourth week which will end the study.

Eligibility criteria:
inclusion criteria: * women who feel that their thighs are too large and the skin is insufficiently smooth. exclusion criteria: * pregnant or nursing

Keywords: lipolytic herbal extracts thigh girth thigh smoothness
effects of regular practice of yoga on subjective and objective sleep quality in primary insomnia

Conditions: Primary Insomnia

Summary: the purpose of the study is to assess the effects of regular viniyoga in patients suffering from primary insomnia.

insomnia is very prevalent in europe (14-27%). cognitive behavioral therapy is the treatment of choice in patients suffering from primary insomnia, allowing to obtain a long term (2 years) sleep quality improvements in 62% of patients. yoga is another behavioral therapy that have shown benefits in patients suffering from anxiety disorders. few studies have been focused on yoga benefits in sleep disorders. the purpose of the study is to assess the effects of regular viniyoga on sleep quality (subjective and objective) in patients suffering from primary insomnia.

Eligibility criteria:
inclusion criteria: -primary insomnia exclusion criteria: * shift work, * associated sleep disorder (sleep apnea, narcolepsy,..)

Keywords: yoga sleep quality sleep quantity sleep efficiency insomnia
use of ranibizumab to treat rubeosis in diabetics prior to cataract surgery

Conditions: Rubeosis Iridis; Proliferative Diabetic Retinopathy

Summary: the purpose of this study was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (pdr) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (pdr).

this is an open-label, phase i study of intravitreally administered 0.5mg ranibizumab in diabetic subjects presenting initially with dense cataract and proliferative diabetic retinopathy induced rubeosis. ten subjects will be enrolled at a single center over a 10 month period. patients will be followed for a total of 12 months in the treatment phase and will have safety follow-ups at months 18 and 24. eligibility for study entry will be determined by the principal investigator. consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every month for 3 doses (loading dose on day 0 and at months 1 and 2) followed by as needed re-treatment based on specified criteria for the remainder of the study period. subjects can receive a maximum of eight injections of ranibizumab during the study. all subjects will undergo cataract surgery after the first ranibizumab injection. only one eye will be designated as the study eye for the duration of the study to receive the ranibizumab injections. all subjects will be evaluated with best corrected early treatment diabetic retinopathy study (etdrs) visual acuity, intraocular pressure measurement, ophthalmological examination, slit lamp photography, gonioscopy, fundus photography, fundus fluorescein angiography and optical coherence tomography (oct). an ultrasound will be done as needed. best corrected etdrs visual acuity and intraocular pressure measurements will be performed on both eyes.

Eligibility criteria:
inclusion criteria: * age 18 years or over * subjects with diabetes mellitus * subjects with proliferative diabetic retinopathy induced rubeosis * be willing to undergo cataract surgery * hgba1c level \< 12% exclusion criteria: * history of glaucoma surgery * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis * intraocular surgery in the study eye within 60 days preceding day 0 * history of prior pars plana vitrectomy in the study eye * positive pregnancy test * hba1c \>12

Keywords: rubeosis neovascularization of iris proliferative diabetic retinopathy pdr cataract
intravenous lidocaine infusion reduce postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy

Conditions: Postoperative Pneumonia; Postoperative Pulmonary Atelectasis; Postoperative Pulmonary Edema

Summary: the goal of this double-center, double-blind, randomized controlled clinical trial is to compare the effect of intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. the main question it aims to answer are whether intravenous lidocaine reduce postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. participants will be given intravenous lidocaine infusion in lidocaine group or placebo in control group.


Eligibility criteria:
inclusion criteria: patients between 18 and 85 years of age with a recent schedule for mie are screened for this study. patients who show clear consciousness and asa status i - iii will be included as eligible participants. exclusion criteria: the exclusion criteria are as follows: patients with severe psychiatric disorders, such as schizophrenia, depression, dementia, etc.; severe hepatic insufficiency (concentration of glutamic oxaloacetic transaminase, glutamic pyruvic transaminase or bilirubin ≥2.5 times the upper limit of normal); renal impairment (creatinine clearance \ 7.55 or ph\<7.2. patients will be discontinued if any of the following situations occur: the patient has an allergic reaction, severe cardiovascular events that cannot be managed with symptomatic treatment, and the patient is unwilling to continue the study.
lidocaine versus diphenhydramine to achieve local anesthesia for laceration repairs

Conditions: Laceration of Skin

Summary: diphenhydramine, when injected locally, has been shown to achieve a certain level of local anesthesia. it has been documented for use in simple bedside procedures, however there is a gap in knowledge in its comparison to lidocaine. the purpose of the study is to determine if local infiltration of diphenhydramine is noninferior to the use of lidocaine 1% when trying to achieve local anesthesia for simple laceration repair. patients who present to the emergency department with a simple laceration will be enrolled in the study. patients will be evaluated for the pain of the injection as well as the pain of the laceration repair procedure post injection.


Eligibility criteria:
inclusion criteria: * lacerations requiring one layer of sutures * lacerations appropriate for repair by emergency physicians exclusion criteria: * active bleeding from laceration * complex lacerations requiring multiple layers * lacerations to be repaired by a specialist service * patients with allergies to either diphenhydramine or lidocaine * laceration repairs would benefit from the use of epinephrine as an additive to the local anesthetic
physical training in patients with relapsing polychondritis

Conditions: Physical Activity

Summary: physical training may improve physical capacity and health parameters in various systemic autoimmune diseases. therefore, the present study will assess the role of an exercise training program in patients with relapsing polychondritis.

impact of physical training in patients with relapsing polychondritis.

Eligibility criteria:
inclusion criteria: * fullfill the classification criteria of mcadam et al. (1976) * using prednisone ≤ 0.5 mg/kg/day in the last three months * sedentary exclusion criteria: * disease relapsing * overlapping disease * chronic and/or current infections (viral, bacterial or fungal) * patients undergoing major surgery within six months before the study * with commitment to ambulation (joint affection in limbs) * smoking * diabetes mellitus
a trial of paclitaxel and bevacizumab vs. gemcitabine, paclitaxel, and bevacizumab in advanced breast cancer

Conditions: Breast Cancer

Summary: this study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer


Eligibility criteria:
inclusion criteria: * females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs. * must be able to measure the disease by specific medical parameters * may have received breast cancer treatment in the early stage of the disease * may be restricted in physically strenuous activity but able to carry out light work. * must have adequate organ function as seen in blood test results. exclusion criteria: * cancer that has spread to the brain. * unstable heart problems * unstable high blood pressure. * breast cancer treatment after the disease has considered to spread to other areas or organs. * unable to agree with the requirements of the study

Keywords: breast cancer cancer of breast cancer of the breast breast neoplasms
a prospective cohort post market registry evaluating outcomes of bridge-enhanced acl restoration (bear®)

Conditions: Anterior Cruciate Ligament Injuries

Summary: the purpose of the bridge registry is to assess real-world performance of the fda approved bear implant.

this is an observational study, where the bear implant will be evaluated in a real-world setting. the registry seeks to enroll consecutive uses of the bear implant at participating sites. there will be a prospective cohort for all subjects scheduled to undergo acl surgery with the bear implant that are willing to provide consent. a retrospective cohort will be available for all subjects treated with a bear implant at each participating site. there is no control group.

Eligibility criteria:
inclusion criteria for prospective cohort: 1. scheduled to undergo acl surgery with the bear implant 2. willing and able to provide informed consent 3. willing and able to complete required follow-up visits and assessments inclusion criteria for retrospective cohort: 1. underwent acl surgery with the bear implant exclusion criteria: 1. the subject is participating in another acl trial or any other clinical trial where the study procedure or treatment might confound the study end point 2. known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the bear implant labeling

Keywords: acl acl surgery acl tear torn acl bear implant bear acl bear restoration bridge-enhanced acl restoration acl restoration acl implant bridge